Patient leaflet - Nobivac LeuFel
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Nobivac LeuFel suspension for injection for cats
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for the batch release
VIRBAC,
1ère avenue 2065 m LID
06516 Carros
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac LeuFel suspension for injection for cats
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1 ml:
Active substance:
Minimum quantity of purified p45 FeLV-envelope antigen 102 ^g
Adjuvants:
3% aluminium hydroxide gel expressed as mg Al3+ 1 mg
Purified extract of Quillaja saponaria 10 ^g
Excipients:
Buffered isotonic solution to 1 ml.
Opalescent liquid.
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4. INDICATION(S)
Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
The onset of immunity has been demonstrated from 3 weeks after the primary vaccination.
After the primary vaccination course, the duration of immunity lasts for one year.
Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A moderate and transient local reaction (<2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced., The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Pain at palpation, sneezing or conjunctivitis may be noted in rare cases. This resolves without any treatment.
Anaphylactic reactions have been reported in very rare cases. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reactions) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cats
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use (under the skin).
Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Primary vaccination:
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– first injection in kittens from eight weeks of age – second injection 3 or 4 weeks later.
Maternally derived antibodies can negatively influence the immune response to vaccination. In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
Re-vaccinations:
Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years.
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9. ADVICE ON CORRECT ADMINISTRATION
Shake the vial gently before use.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life after first opening the container: use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
Special precautions for use in animals:
De-worming at least 10 days prior to vaccination is recommended.
Only feline leukaemia virus (FeLV) negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
Do not use in pregnant cats. The use is not recommended during lactation.
Interaction with other medicinal products and other forms of interaction:
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP and FELIGEN RCP. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after another veterinary medicinal product therefore needs to be made on a case by case basis.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Incompatibilities:
Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION